Specialist Quality Assurance

Description:

Title: Specialist Quality Assurance

Location: Providence RI

Contract Duration: 12 months

Pimary Responsibilities:

• Own and/or QA Approve Minor and Major Deviations for the Corporate Quality Management System’s (CQMS) team - Deviation/CAPA functional area and Corporate functions that do not have Quality oversight
• Own and/or QA Approve CAPA and Effectiveness Verification (EV) records
• Support annual trend verification report
• Support deviation proficiency evaluation program
• Support system Business Owner responsibilities such as defining user requirements, drafting data integrity assessments, drafting test scripts/protocols for user testing, ALM testing
• Own and/or QA Approve Deviation & CAPA process documentation including work instructions, SOPs, and training materials
• Coordinate Investigation Advisory Board (IAB) meetings for multisite and CQMS deviations
• Provide support/advice to deviation management system (DQMS) users and approve IS tickets for record updates
• Review and approve Change Controls (QA Contact role)
• Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)
• Anticipate and prevent potential problems
• Lead/support continuous improvement projects related to the Deviation/CAPA process
• Provide training for Deviation/CAPA Instructor Led Training sessions
• Independently develop solutions that are thorough, practical and consistent with functional objectives
• Bring critical events or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes
• Admin activities may include the following: maintenance of Deviation/CAPA Smartsheets and distribution lists, querying in deviation management system for data collection/analysis, data gathering for metrics

Preferred Qualifications

• Experience owning/approving Major and Minor Deviations
• Technical knowledge of IS systems and validation from Business Owner perspective for systems that are used to support the Deviation process
• Excellent written and verbal communication skills
• Strong organizational skills
• Experience in AI related projects
• Knowledge of industry and business principles
• Demonstrated problem solving abilities
• Demonstrated project management skills
• Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
• Provides training and guidance to others
• Extends capabilities by working closely with senior staff/ experts within the internal organization

Salary and Other Compensation:

The annual [salary/hourly rate] for this position is between $28.00 - $29.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

[medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance],

[paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].